ID

26107

Description

Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. End of Study Record

    English

    End of Study Record

    1 forms  
    1. StudyEvent: ODM
      1. End of Study Record
    End of Study Record
    Description

    End of Study Record

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C0444930
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of subject completion or discontinuation from the study
    Description

    Date of subject completion or discontinuation from the study

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2348577
    UMLS CUI [1,2]
    C0011008
    Time of subject completion or discontinuation from the study
    Description

    Time of subject completion or discontinuation from the study

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2348577
    UMLS CUI [1,2]
    C0040223
    Did the subject become pregnant during the study?
    Description

    If YES, record details on PREGNANCY NOTIFICATION FORM.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961
    Did the subject discontinue the study prematurely?
    Description

    premature discontinuation of study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0457454
    UMLS CUI [1,2]
    C2348568
    Primary reason for premature discontinuation
    Description

    premature discontinuation of study

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0457454
    UMLS CUI [1,2]
    C2348568
    Specify other reason for discontinuation
    Description

    Other reason for discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0457454
    UMLS CUI [1,2]
    C3840932
    Investigator Comment Log
    Description

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    Date of comment
    Description

    Date of comment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0011008
    CRF page number if applicable
    Description

    page number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1704732
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    Description

    Investigator's Statement

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C1710187
    Date of completion
    Description

    Date of completion

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0850287
    Investigators signature
    Description

    Investigators signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigators name-print
    Description

    Investigators name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    End of Study Record

    1 forms
    1. StudyEvent: ODM
      1. End of Study Record
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    End of Study Record
    C0008976 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Date of subject completion or discontinuation from the study
    Item
    Date of subject completion or discontinuation from the study
    date
    C2348577 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of subject completion or discontinuation from the study
    Item
    Time of subject completion or discontinuation from the study
    time
    C2348577 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Pregnancy
    Code List
    Did the subject become pregnant during the study?
    CL Item
    No (N)
    CL Item
    Not Applicable (not of childbearing potential or male) (X)
    CL Item
    Yes (Y)
    premature discontinuation of study
    Item
    Did the subject discontinue the study prematurely?
    boolean
    C0457454 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    Item
    Primary reason for premature discontinuation
    text
    C0457454 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    premature discontinuation of study
    Code List
    Primary reason for premature discontinuation
    CL Item
    Adverse event (A)
    CL Item
    Consent withdrawn (C)
    CL Item
    Lost to follow up (L)
    CL Item
    Protocol violation (P)
    CL Item
    Other (X)
    Other reason for discontinuation
    Item
    Specify other reason for discontinuation
    text
    C0457454 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    Date of comment
    Item
    Date of comment
    date
    C0947611 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    page number
    Item
    CRF page number if applicable
    integer
    C1704732 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Investigator's Statement
    Item
    I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    boolean
    C0008961 (UMLS CUI [1,1])
    C1710187 (UMLS CUI [1,2])
    Date of completion
    Item
    Date of completion
    date
    C0011008 (UMLS CUI [1,1])
    C0850287 (UMLS CUI [1,2])
    Investigators signature
    Item
    Investigators signature
    text
    C2346576 (UMLS CUI [1])
    Investigators name
    Item
    Investigators name-print
    text
    C2826892 (UMLS CUI [1])
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